Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients
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Purpose
This study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as TMS) to see if this can make a difference in the condition of people with Alzheimer's disease by improving their disease and the cognitive decline that goes along with it.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Behavioral: NICE Cognitive Training |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study |
- Alzheimer's Disease Assessment Scale (ADAS-Cog) [ Time Frame: Pre treatment; post treatment; 1, 2, and 3 months post treatment ] [ Designated as safety issue: No ]Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention.
- Weschler Test of Adult Reading (WTAR) [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]Brief test to estimate level of intelligence
- Clinical Global Impression Change (CGIC) [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]A three-item scale used to assess treatment response in psychiatric patients. They are severity of illness, global improvement, and efficacy index.
- Modified Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Pre-treatment; post treatment; 1, 2, and 3 months post treatment ] [ Designated as safety issue: No ]Assess immediate and delayed memory function.
- NACC's UDS Neuropsychological Battery Test [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]
Consists of:
- Logical memory (immediate and delayed)
- Digit span forward
- Digit span backward
- Category fluency (animals and vegetables)
- WAIS-R Digit symbol
- Boston naming test
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active rTMS
High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
|
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. Other Names:
Behavioral: NICE Cognitive Training
12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. Other Names:
|
|
Sham Comparator: Sham rTMS
High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).
|
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. Other Names:
Behavioral: NICE Cognitive Training
12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. Other Names:
|
Detailed Description:
This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center. The treatment portion of the study requires patients to visit the BIDMC daily, Monday through Friday, for 6 weeks. All participants will receive real cognitive training, but half of our participants will receive active TMS treatment and half will receive a placebo TMS treatment. However, those receiving the placebo treatment will be offered the real treatment upon the completion of the study. This study goes up to approximately 4.5 months.
TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular region of your brain and that, coupled with the cognitive training, is what is being looked at in this study. The investigators are examining if this combination of TMS and cognitive training will improve your memory function and other mental functions such as language, orientation, and thinking or judgment.
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female age 55-90
- Diagnosed with mild to moderate AD according to DSM-IV criteria
- Diagnosis of dementia of the Alzheimer's type according to the criteria established by the NINCDS-ADRDA
- Normal or corrected normal ability to see and hear
- Primary language is English
Exclusion Criteria:
- IQ below 85
- Any major structural abnormalities on MRI (eg. Infarction, intracerebral malformation)
- Any symptoms of disease or abnormalities sufficient to cause memory impairment other than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)
- Any functional psychiatric disorder (eg. Schizophrenia)
- Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. Cardiac malformation)
- History of seizures, diagnosis of epilepsy
- Metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit (unless removed completely for this study), cerebral spinal fluid shunt
- Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate
Contacts and Locations| Contact: Natasha J Atkinson, B.A. | 617-667-0258 | natkinso@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Natasha J Atkinson, B.A. 617-667-0258 natkinso@bidmc.harvard.edu | |
| Contact: Ann Connor, R.N. 617-667-0269 aconnor@bidmc.harvard.edu | |
| Principal Investigator: Alvaro Pascual-Leone, M.D., Ph.D. | |
| Sub-Investigator: Ann Connor, R.N. | |
| Sub-Investigator: Anna-Katharine Brem, Ph.D. | |
| Principal Investigator: | Alvaro Pascual-Leone, M.D., Ph.D. | Beth Israel Deaconess Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01504958 History of Changes |
| Other Study ID Numbers: | 2010P-000325 |
| Study First Received: | September 29, 2011 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Beth Israel Deaconess Medical Center:
|
Alzheimer's disease Cognitive Training Transcranial Magnetic Stimulation |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013